The European Commission (EC) has approved the expanded use of Janssen’s Spravato for the rapid reduction of depressive symptoms in a psychiatric emergency, for adult patients with a moderate-to-severe episode of major depressive disorder (MDD).
Spravato (esketamine nasal spray) is to be co-administered with oral antidepressant therapy in the specified patient population.
The approval was based on data from the Phase III ASPIRE I & II clinical studies, which compared the efficacy and safety of Spravato in combination with comprehensive standard of care (SOC) to placebo nasal spray plus comprehensive SOC in adults with moderate-to-severe MDD and current/active suicidal ideation with intent.
The primary efficacy measure across each study was the reduction of symptoms of MDD, as measured by the change from baseline Montgomery-Åsberg Depression Rating Scale (MADRS) total score at 24 hours after the first dose.
Patients who received Spravato treatment, plus comprehensive SOC, achieved a difference of -3.8 in depressive symptoms at 24 hours after receiving the first dose compared to placebo – a statistically significant and clinically meaningful reduction.
According to Janssen, the benefit of Spravato plus comprehensive SOC on symptoms of MDD was apparent as early as four hours after the first dose.
However, the effectiveness of Spravato in preventing suicide or reducing suicidal ideation or behaviour was not demonstrated.
“This authorisation of esketamine nasal spray by the European Commission is a welcome and significant step toward reducing the burden faced by many adults with major depressive disorder in Europe, and is part of Janssen’s commitment to patients with serious mental illnesses,” said Tito Roccia, therapeutic area medical affairs director, neuroscience, Janssen-Cilag Ltd.
“This new indication for esketamine nasal spray provides psychiatrists with an innovative treatment option to help their adult patients needing urgent relief from debilitating symptoms during a psychiatric emergency based on clinical judgment,” he added.
